# FDA 483 - Kofinas Fertility Group - July 25, 2023

Source: https://www.keypedia.com/records/483/kofinas-fertility-group/f93f6c79-4dfe-433d-a3d7-50fe72da9871

> FDA 483 for Kofinas Fertility Group on July 25, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kofinas Fertility Group
- Inspection Date: 2023-07-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The Kofinas Fertility Group in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in determining and documenting HCT/P donor eligibility, including issues with record accuracy, legibility, and inadequate screening for infectious disease risks like Zika Virus. These findings indicate a failure to ensure the safety and suitability of donated oocytes.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/kofinas-fertility-group/09d3a33d-78bd-4b53-9d89-474a34b3aecf

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961